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EP3334380B1 - Valve cardiaque rétractable, comprenant des stents ayant des armatures coniques - Google Patents

Valve cardiaque rétractable, comprenant des stents ayant des armatures coniques Download PDF

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Publication number
EP3334380B1
EP3334380B1 EP16753785.1A EP16753785A EP3334380B1 EP 3334380 B1 EP3334380 B1 EP 3334380B1 EP 16753785 A EP16753785 A EP 16753785A EP 3334380 B1 EP3334380 B1 EP 3334380B1
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EP
European Patent Office
Prior art keywords
struts
width
commissure
heart valve
proximal
Prior art date
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EP16753785.1A
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German (de)
English (en)
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EP3334380A1 (fr
Inventor
Kristopher H. Vietmeier
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St Jude Medical Cardiology Division Inc
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St Jude Medical Cardiology Division Inc
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Definitions

  • the present invention relates to heart valve replacement and, in particular, to collapsible prosthetic heart valves. More particularly, the present invention relates to collapsible prosthetic heart valves including stents with tapered struts for fatigue resistance.
  • Prosthetic heart valves that are collapsible to a relatively small circumferential size can be delivered into a patient less invasively than valves that are not collapsible.
  • a collapsible valve may be delivered into a patient via a tube-like delivery apparatus such as a catheter, a trocar, a laparoscopic instrument, or the like. This collapsibility can avoid the need for a more invasive procedure such as full open-chest, open-heart surgery.
  • Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent.
  • a stent There are two types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent.
  • a self-expanding stent To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size.
  • the prosthetic valve When a collapsed prosthetic valve has reached the desired implantation site in the patient (e.g ., at or near the annulus of the patient's heart valve that is to be replaced by the prosthetic valve), the prosthetic valve can be deployed or released from the delivery apparatus and re-expanded to full operating size.
  • this generally involves releasing the entire valve, assuring its proper location, and then expanding a balloon positioned within the valve stent.
  • the stent automatically expands as the sheath covering the valve is withdrawn.
  • WO2014/203106 discloses a collapsible prosthetic heart valve.
  • US2014/277389 discloses a radiopaque transcatheter valve and anatomical markers.
  • US2015/209140 discloses a stented prosthetic heart valve with variable stiffness and methods of use.
  • US2014/142693 discloses valve prosthesis frames.
  • a prosthetic heart valve comprising: a collapsible and expandable stent having an annulus section adjacent a proximal end, an aortic section adjacent a distal end, a transition section tapering outwardly from the annulus section to the aortic section, and a plurality of commissure features disposed between the proximal end and the distal end, the stent including a plurality of struts, selected ones of the struts being directly coupled to the commissure features and having multiple widths along their length and being wider adjacent the commissure features than at select locations spaced away from the commissure features; and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets, two adjacent leaflets forming a leaflet commissure directly connected to the plurality of commissure features, the valve assembly configured to allow blood to flow from the annulus section toward the aortic section and to prevent blood from flowing from the aortic section toward the annulus section, characterized
  • a prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, and a plurality of commissure features disposed between the proximal end and the distal end, the stent including a plurality of struts, selected ones of the struts having multiple widths along their length and being wider adjacent the commissure features than at select locations spaced away from the commissure features, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features.
  • a stent for a prosthetic heart valve having a proximal end and a distal end may include a plurality of commissure features disposed between the proximal end and the distal end, and a plurality of struts, selected ones of the struts having multiple widths along their length and being wider adjacent the commissure features than at select locations spaced away from the commissure features.
  • proximal when used in connection with a prosthetic heart valve, refers to the end of the heart valve closest to the heart when the heart valve is implanted in a patient
  • distal when used in connection with a prosthetic heart valve, refers to the end of the heart valve farthest from the heart when the heart valve is implanted in a patient.
  • the words “substantially,” “approximately,” “generally” and “about” are intended to mean that slight variations from absolute are included within the scope of the structure or process recited.
  • FIG. 1 shows a collapsible prosthetic heart valve 100 including a collapsible stent 102 and a valve assembly 104.
  • Prosthetic heart valve 100 is designed to replace a native tricuspid valve of a patient, such as a native aortic valve.
  • a native aortic valve such as a native aortic valve.
  • the devices disclosed herein are described predominantly in connection with their use to replace a native aortic valve, and are described as having a stent with a shape as illustrated in Fig. 1 , the valve could be a bicuspid or other valve, such as the mitral valve, and the stent could have a shape that differs from that shown.
  • the expandable stent 102 of prosthetic heart valve 100 may be formed from biocompatible materials that are capable of self-expansion, such as, for example, shape-memory alloys, such as the nickel-titanium alloy known as "nitinol," or other suitable metals or polymers.
  • Stent 102 extends in a length direction L from proximal or annulus end 110 to distal or aortic end 112, and includes annulus section 120 adjacent proximal end 110, transition section 121, and aortic section 122 adjacent distal end 112.
  • Annulus section 120 has a relatively small cross-section in the expanded condition
  • aortic section 122 has a relatively large cross-section in the expanded condition.
  • annulus section 120 is in the form of a cylinder having a substantially constant diameter along its length.
  • Transition section 121 may taper outwardly from annulus section 120 to aortic section 122.
  • Stent 102 may also have different shapes, such as a flared or conical annulus section, a less bulbous aortic section, and the like, and a differently shaped transition section 121.
  • Each of the sections of stent 102 may be laser cut from a tube to create a plurality of struts 130 forming cells 132 connected to one another in one or more annular rows around the stent. For example, as shown in Fig.
  • annulus section 120 may have two annular rows of complete cells 132 and aortic section 122 and transition section 121 may each have one or more annular rows of partial cells 132.
  • Cells 132 in aortic section 122 may be larger than cells 132 in annulus section 120 to better enable prosthetic valve 100 to be positioned in the native valve annulus without the stent structure interfering with blood flow to the coronary arteries.
  • Each of cells 132 has a length in length direction L of the stent and a width in a perpendicular direction W.
  • Stent 102 may include one or more retaining elements 134 at distal end 112 thereof, retaining elements 134 being sized and shaped to cooperate with corresponding recesses in a retainer of a device for delivering prosthetic heart valve 100 into a patient.
  • the engagement of retaining elements 134 with the retainers of the delivery device helps maintain prosthetic heart valve 100 in assembled relationship with the delivery device, minimizes longitudinal movement of the prosthetic heart valve relative to the delivery device during unsheathing or resheathing procedures, and helps prevent rotation of the prosthetic heart valve relative to the delivery device as the delivery device is advanced to the target location and the heart valve deployed.
  • Valve assembly 104 of prosthetic heart valve 100 preferably is positioned in annulus section 120 of stent 102 and secured to the stent.
  • Valve assembly 104 includes cuff 136 and a plurality of leaflets 138 which collectively function as a one way valve by coapting with one another.
  • valve 100 has three leaflets 138.
  • cuff 136 is shown in Fig. 1 as being disposed on the luminal or inner surface of annulus section 120, it is contemplated that cuff 136 may be disposed on the abluminal or outer surface of annulus section 120 or may cover all or part of either or both of the luminal and abluminal surfaces. Both cuff 136 and leaflets 138 may be wholly or partly formed of any suitable biological material or polymer such as, for example, polytetrafluoroethylene (PTFE).
  • PTFE polytetrafluoroethylene
  • Leaflets 138 may be attached along their belly portions to cuff 136 and/or to stent 102, with the commissure between adjacent leaflets 138 being attached to a commissure feature 140.
  • each commissure feature 140 may lie at the intersection of four cells 132, two of the cells being adjacent one another in the same annular row, and the other two cells being in different annular rows and lying in end to end relationship.
  • commissure features 140 are positioned entirely within annulus section 120 or at the juncture of annulus section 120 and transition section 121.
  • Commissure features 140 may include one or more eyelets which facilitate the suturing of the leaflet commissure to stent 102.
  • commissure features 140 may include one, two, three, four, five or six or more eyelets arranged in rows and/or columns.
  • the eyelets may be formed of the same shape and/or size and sutures may be passed through any combination of the eyelets as desired.
  • Prosthetic heart valve 100 may be used to replace a native aortic valve, a surgical heart valve or a heart valve that has undergone a surgical procedure.
  • Prosthetic heart valve 100 may be delivered to the desired site (e.g., near the native aortic annulus) using any suitable delivery device.
  • prosthetic heart valve 100 is disposed inside a compartment of a delivery device in the collapsed condition.
  • the delivery device may be introduced into a patient using a transfemoral, transapical, transseptal or any other percutaneous approach.
  • the user may deploy prosthetic heart valve 100.
  • prosthetic heart valve 100 expands so that annulus section 120 is in secure engagement within the native aortic annulus.
  • prosthetic heart valve 100 When prosthetic heart valve 100 is properly positioned inside the heart, it works as a one-way valve, allowing blood to flow from the left ventricle of the heart to the aorta, and preventing blood from flowing in the opposite direction.
  • FIG. 2 illustrates one version of a commissure feature 200 coupled to prior struts 214a,214b for attaching a valve assembly to the stent.
  • Commissure feature 200 has a body 202 with a pair of eyelets 204.
  • Leaflets may be attached via sutures, staples, glue or any other suitable means to commissure feature 200, such as by passing sutures through eyelets 204 and wrapping them around struts 214a,214b.
  • the load exerted on the commissure feature 200 by the attached leaflets is distributed across the entire area of commissure feature 200.
  • FIG. 3 illustrates a commissure feature 300 coupled to prior art struts 314a,314b.
  • Commissure feature 300 has a body 302 extending between proximal end 301p and distal end 301d, the body having a plurality of substantially square eyelets 304 arranged in rows and/or columns, and an elongated eyelet 306 disposed adjacent proximal end 301p.
  • Body 302 further includes a pair of notches 307 for receiving sutures.
  • Leaflets may be attached via sutures, glue, staples or any suitable means to commissure feature 300, such as by passing sutures through eyelets 304,306 and by wrapping the sutures around struts 314a,314b.
  • commissure feature 300 Stress from the leaflets is distributed across the entire area of the commissure feature 300. Because commissure feature 300 has a larger overall area than commissure feature 200, commissure feature 300 provides a larger area across which the stress from the leaflets is distributed when compared to the area of commissure feature 200. A larger area for distributing loads may decrease the chance of leaflet failure at the commissure feature-leaflet attachment.
  • struts 314a are coupled to body 302 adjacent proximal end 301p and struts 314b are coupled to body 302 adjacent distal end 301d.
  • a first intersection 316 is formed at the junctions between struts 314a and body 302
  • a second intersection 318 is formed at the junctions between struts 314b and body 302, the intersections being in the form of abrupt transitions forming approximately a right angle between struts 314a,314b and body 302.
  • intersections 316, 318 act as stress concentrators, such that the stresses acting on commissure feature 300 from the leaflets may be concentrated at these intersections.
  • the excess stress at intersections 316,318 and adjacent portions of the stent may make them prone to failure due to fatigue.
  • FIG. 4A illustrates a commissure feature 400 coupled to tapered struts 414a,414b according to one embodiment of the present disclosure.
  • Commissure feature 400 has a body 402 extending between proximal end 401p and distal end 401d, the body having a plurality of substantially square eyelets 404 arranged in rows and/or columns, and an elongated eyelet 406 disposed adjacent proximal end 401p.
  • Body 402 further includes a pair of notches 407 for receiving sutures.
  • Leaflets may be attached via sutures, glue, staples or any suitable means to commissure feature 400. For example, the attachment may be made by passing sutures through the leaflets and through eyelets 404, 406 of commissure feature 400 and wrapping them around struts 414a,414b.
  • Struts 414a are coupled to body 402 adjacent proximal end 401p and struts 414b are coupled to body 402 adjacent distal end 401d.
  • tapered struts 414a, 414b gradually increase in width toward the commissure feature.
  • struts 414a may have a first width w1 at a spaced distance from commissure feature 400 that is approximately 0.25 mm, and a second width w2 immediately adjacent commissure feature 400 that is approximately 0.5mm, the second width w2 being the widest portion of the strut.
  • width w1 is approximately one-half or one-third of width w2.
  • each strut 414a may have the first width w1, with only a small portion of the strut having a width that is greater than w1. In at least some examples, approximately 70% to approximately 80% of each strut 414a has the first width w1, with the remaining portion having widths that gradually increase until reaching width w2.
  • a smooth curve 416 is defined along the outside edge of each strut 414a between first width w1 and second width w2. Smooth curve 416 may have a single radius of curvature or multiple radii. The gradual increase in width along curve 416 provides a generally smooth transition from strut 414a to body 402 such that an obtuse angle of between about 120 degrees and about 170 degrees is formed therebetween.
  • a stent may be laser cut from a tube 490 having a wall thickness t1 into a plurality of struts forming cells as shown in FIG. 1 . After laser cutting, the thickness of each strut will be equal to the initial wall thickness t1 of the tube. Width w1 may be less than or equal to the thickness t1 of the struts, while width w2 may be greater than the thickness t1 of the struts.
  • strut 414b may have a first width w1 that is approximately equal to the first width of strut 414a, and a third width w3 immediately adjacent commissure feature 400 that is between about 0.25 and about 0.3 mm, the third width w3 being the widest portion of the strut.
  • the majority of each strut 414b may have the first width w1, with only a small portion of the strut having a width that is greater than w1.
  • approximately 70% to approximately 80% of strut 414b has the first width w1 with the remaining portion having gradually increasing widths until width w3.
  • a second smooth curve 418 is defined along the outside edge of each strut 414b between first width w1 and third width w3, the gradual increase in width along curve 418 providing a generally smooth transition from strut 414b to body 402 such that an obtuse angle of at least between about 120 degrees and about 170 degrees is formed therebetween.
  • Smooth curve 418 may have a single radius of curvature or multiple radii.
  • a curve is formed from width w1 to width w3, the curve having a radius of curvature of about 5mm to about 75 mm.
  • curvatures and widths discussed herein are merely exemplary and not to be taken as limiting.
  • struts 414a have been described as being coupled to body 402 adjacent proximal end 401p, but the widths and/or curvatures associated with each of struts 414a need not be the same (e.g., only one of struts 414a may include an increased width, or one of the struts may be wider than another of struts 414a).
  • struts 414b have been described as being coupled to body 402 adjacent distal end 401d, but the widths and/or curvatures associated with each of struts 414b need not be the same (e.g., only one of struts 414b may include an increased width, or one of the struts may be wider than another of struts 414b). Moreover, upper struts 414a and lower 414b may have different curvatures and/or widths from each other.
  • fatigue performance of a strut is at least partly determined by the overall dimensions of the stent (e.g., strut width, strut thickness, strut length, cell density. Fatigue resistance may also need to be balanced with the radial force exerted by or on the stent. For example, increasing the width of the struts may increase the fatigue resistance of the strut, but at the same time it may reduce the crimpability of the stent and/or increase the radial force exerted by the stent on body tissue when implanted. By providing a gradually increasing strut width at only preselected locations, fatigue performance may be improved at high strain areas, while the stent's chronic outward force may be optimized.
  • a predetermined curvature or curvatures may be formed at certain regions of the struts that couple to a commissure feature, providing those struts with a gradually increasing width closer to the commissure feature.
  • a curvature may be implemented on all struts that join to a commissure feature, or on only certain struts that experience high strain (e.g., only struts 414a, only struts 414b or some combination of the two).
  • curvature may be implemented in struts that join to commissure features that are not generally rectangular (e.g., the egg-shaped commissure of Fig. 2 ).
  • regions of the stent above commissure feature 500 are prone to failure due to high strain. No appreciable strain was measured at the commissure notch.
  • a reduced strain is apparent in certain regions of the stent, such as region 560 of strut 552.
  • the inclusion of tapers in the form of curved edges as described above with reference to FIG. 4A permits the distribution of strain over a larger area, reducing strain concentration in discrete areas.
  • the increase in width is merely local (e.g., along discrete portions of a strut)
  • the performance of the device e.g., crimpability of the stent, anchoring of the stent, etc.
  • the preceding embodiments may result in a reduction in maximum strain within the stent.
  • the tapering of struts may be utilized in any area in addition to, or instead of, areas discussed above that are adjacent to a commissure attachment feature.
  • tapered struts are formed in stents having no commissure features.
  • struts may be tapered as described above adjacent areas of high strain to reduce the peak strain in those areas.
  • a prosthetic heart valve may include a collapsible and expandable stent having a proximal end, a distal end, and a plurality of commissure features disposed between the proximal end and the distal end, the stent including a plurality of struts, selected ones of the struts having multiple widths along their length and being wider adjacent the commissure features than at select locations spaced away from the commissure features, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features; and/or
  • a stent for a prosthetic heart valve having a proximal end and a distal end may include a plurality of commissure features disposed between the proximal end and the distal end, and a plurality of struts, selected ones of the struts having multiple widths along their length and being wider adjacent the commissure features than at select locations spaced away from the commissure features; and/or

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Claims (12)

  1. Valvule cardiaque prothétique (100), comprenant :
    un stent rétractable et extensible (102) ayant une section d'anneau (120) adjacente à une extrémité proximale (110), une section aortique (122) adjacente à une extrémité distale (112), une section de transition (121) s'effilant vers l'extérieur de la section d'anneau à la section aortique et une pluralité d'éléments de commissure (400) disposés entre l'extrémité proximale et l'extrémité distale, le stent comportant une pluralité d'armatures (130, 414a, 414b), celles sélectionnées (414a, 414b) des armatures étant directement accouplées aux éléments de commissure et ayant de multiples largeurs (w1, w2, w3) sur leurs longueurs et étant plus larges à côté des éléments de commissure qu'au niveau des emplacements choisis espacés des éléments de commissure ; et
    un ensemble de valvule rétractable et extensible (104), l'ensemble de valvule comportant une pluralité de feuillets (138), deux feuillets adjacents formant une commissure de feuillet directement reliée à la pluralité d'éléments de commissure, l'ensemble de valvule étant conçu pour permettre au sang de s'écouler de la section d'anneau vers la section aortique et pour empêcher le sang de s'écouler de la section aortique vers la section d'anneau,
    caractérisé en ce que les armatures sélectionnées parmi les armatures comportent une première paire d'armatures proximales (414a) accouplées chacune à une extrémité proximale (401p) de l'un des éléments de commissure au niveau d'une jonction proximale et s'étendant à l'intérieur de la section d'anneau vers l'extrémité proximale du stent, et une seconde paire d'armatures distales (414b) accouplées chacune à une extrémité distale (401d) de l'un des éléments de commissure au niveau d'une jonction distale et s'étendant à l'intérieur de la section de transition vers l'extrémité distale du stent.
  2. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune de la première paire d'armatures proximales (414a) est la plus large (w2) au niveau de la jonction proximale et chacune de la seconde paire d'armatures distales (414b) est la plus large (w3) au niveau de la jonction distale.
  3. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune des armatures proximales (414a) a une première largeur (w1) à une distance espacée de l'élément de commissure (400).
  4. Valvule cardiaque prothétique (100) selon la revendication 3, dans laquelle chacune des armatures proximales (414a) a une deuxième largeur (w2) adjacente à l'élément de commissure (400) qui est approximativement deux fois plus large que la première largeur (w1).
  5. Valvule cardiaque prothétique (100) selon la revendication 4, dans laquelle la première largeur (w1) est inférieure à une épaisseur (t1) de chacune des armatures proximales (414a) et la deuxième largeur (w2) est supérieure à l'épaisseur de chacune des armatures proximales.
  6. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune des armatures proximales (414a) a une première largeur (w1) et une deuxième largeur (w2) qui est supérieure à la première largeur, environ 70 % à environ 80 % d'une longueur de chacune des armatures proximales ayant la première largeur et une partie restante de la longueur de chacune des armatures proximales ayant des largeurs qui augmentent progressivement de la première largeur à la deuxième largeur.
  7. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune des armatures distales (414b) a une première largeur (w1) à une distance espacée de l'extrémité distale (401d) de l'élément de commissure (400) qui est d'environ 0,25 mm.
  8. Valvule cardiaque prothétique (100) selon la revendication 7, dans laquelle chacune des armatures distales (414b) a une autre largeur (w3) adjacente à l'extrémité distale (401d) de l'élément de commissure (400) qui est d'environ 0,5 mm.
  9. Valvule cardiaque prothétique (100) selon la revendication 8, dans laquelle la première largeur (w1) est inférieure à une épaisseur (t1) de chacune des armatures distales (414b) et l'autre largeur (w3) est supérieure à l'épaisseur de chacune des les armatures distales.
  10. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune des armatures distales (414b) a une première largeur (w1) et une troisième largeur (w3) qui est supérieure à la première largeur, 'environ 70 % à environ 80 % d'une longueur de chacune des armatures distales ayant la première largeur et une partie restante de la longueur de chacune des armatures distales ayant des largeurs qui augmentent progressivement de la première largeur à la troisième largeur.
  11. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle celles sélectionnées des armatures (414a, 414b) sont effilées avec une courbure progressive qui fournit une transition généralement en douceur vers un corps (402) de l'élément de commissure (400), la transition en douceur ayant une encoche (407) pour recevoir une suture.
  12. Valvule cardiaque prothétique (100) selon la revendication 1, dans laquelle chacune des éléments de commissure (400) comporte un corps (402) qui est sensiblement rectangulaire.
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US20090216312A1 (en) 2008-02-26 2009-08-27 Helmut Straubinger Stent for the Positioning and Anchoring of a Valvular Prosthesis in an Implantation Site in the Heart of a Patient
US20110238168A1 (en) 2010-03-25 2011-09-29 Medtronic, Inc. Stents for Prosthetic Heart Valves
WO2014004806A1 (fr) 2012-06-29 2014-01-03 St. Jude Medical, Cardiology Division, Inc. Ensemble valvule cardiaque à endoprothèse ayant des caractéristiques de fixation de lame valvulaire
WO2014004822A1 (fr) 2012-06-29 2014-01-03 St. Jude Medical, Cardiology Division, Inc. Caractéristique de fixation de commissure pour valvule cardiaque prothétique
US20140142693A1 (en) 2012-11-20 2014-05-22 Medtronic, Inc Valve Prosthesis Frames
US20150066141A1 (en) 2013-09-04 2015-03-05 St. Jude Medical, Cardiology Division, Inc. Commissure attachment features for improved delivery flexibility and tracking
WO2017027541A1 (fr) 2015-08-12 2017-02-16 St. Jude Medical, Cardiology Division, Inc. Valve cardiaque rétractable, comprenant des stents ayant des armatures coniques

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US12053369B2 (en) 2011-11-23 2024-08-06 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US12138159B2 (en) 2012-02-14 2024-11-12 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US11497602B2 (en) 2012-02-14 2022-11-15 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US12109111B2 (en) 2015-12-15 2024-10-08 Neovasc Tiara Inc. Transseptal delivery system
US12193932B2 (en) 2016-01-29 2025-01-14 Neovasc Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
US12201524B2 (en) 2016-11-21 2025-01-21 Neovasc Tiara Inc. Methods and systems for rapid retraction of a transcatheter heart valve delivery system
US11793640B2 (en) 2017-08-25 2023-10-24 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US11737872B2 (en) 2018-11-08 2023-08-29 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
US11998447B2 (en) 2019-03-08 2024-06-04 Neovasc Tiara Inc. Retrievable prosthesis delivery system
US11602429B2 (en) 2019-04-01 2023-03-14 Neovasc Tiara Inc. Controllably deployable prosthetic valve
US12036117B2 (en) 2019-04-10 2024-07-16 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11931254B2 (en) 2019-06-20 2024-03-19 Neovasc Tiara Inc. Low profile prosthetic mitral valve

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WO2017027541A1 (fr) 2017-02-16
US10368983B2 (en) 2019-08-06
EP3334380A1 (fr) 2018-06-20
US20170042673A1 (en) 2017-02-16

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